MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE PROBE - STRAIGHT LUMBAR

Catalog Number 07.02067.001

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that the tip of a probe became stuck within the bone during use, and the tip twisted while being loosened from the bone.There were no reported patient impacts associated with this event.

Manufacturer Narrative

Udi number: (b)(4).Additional information: without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that the tip of a probe became stuck within the bone during use, and the tip twisted while being loosened from the bone.There were no reported patient impacts associated with this event.

Manufacturer Narrative

Additional information: method, results, and conclusions - the returned probe was evaluated.The tip was found to be twisted as reported.The event description stated that the patient had very hard bone.It is likely that while trying to create the hole, this hard bone overcame the mechanical capabilities of the device and led to material fatigue/deformation as was seen.A review of the manufacturing records did not identify any issues which would have contributed with this event.

Event Description

It was reported that the tip of a probe became stuck within the bone during use, and the tip twisted while being loosened from the bone.There were no reported patient impacts associated with this event.

• Brand Name: PEDICLE PROBE - STRAIGHT LUMBAR
• Type of Device: PROBE
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7952283
• MDR Text Key: 123257762
• Report Number: 3012447612-2018-00800
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02067.001
• Device Lot Number: 63040720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1